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An innovative next-generation endoscopic submucosal injection material with a 2-step injection system (with video)

      Background and Aims

      Next-generation submucosal injection materials (SIMs) with higher performance and flexibility than the current SIMs (eg, 0.4% sodium hyaluronate solution [HA]) are expected to improve the outcomes of endoscopic submucosal dissection (ESD) but are difficult to develop. We developed a next-generation SIM by devising a 2-solution-type SIM comprising 2.0% calcium chloride solution (Ca) and 0.4% sodium alginate solution (SA) and evaluated its performance.

      Methods

      Viscoelasticity, submucosal elevation height, and injection pressure of HA, SA, and the next-generation SIM were measured. Outcomes of ESDs on pseudo-lesions in ex vivo porcine stomach/colon models were compared.

      Results

      The dramatic increase in SA viscoelasticity with the addition of Ca facilitated the formation of highly viscous submucosal cushions that can be controlled by endoscopists. The submucosal elevation height of the next-generation SIM was significantly higher than that of HA or SA with the same injection pressure. The ESD procedure time using the next-generation SIM was significantly shorter than that using HA or SA (14.2 ± 6.1 vs 29.2 ± 9.1 minutes, P = .0004, or 14.2 ± 6.1 vs 29.1 ± 5.9 minutes, P <.0001). Furthermore, the total injection volume for the next-generation SIM was considerably lower than that for HA or SA (7.0 ± 0.9 vs 17.2 ± 3.4 mL, P <.0001, or 7.0 ± 0.9 vs 16.2 ± 2.9 mL, P <.0001).

      Conclusions

      We developed an ideal next-generation SIM that achieved high performance and high flexibility in ex vivo models. Our findings warrant further investigations in a patient population.

      Abbreviations:

      Ca (calcium chloride aqueous solution), ESD (endoscopic submucosal dissection), HA (sodium hyaluronate aqueous solution), IP (injection pressure), SA (sodium alginate aqueous solution), SEH (submucosal elevation height), SIM (submucosal injection material), VAS (visual analog scale)
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      Linked Article

      • Performance comparison between next-generation and shear-thinning hydrogel-based submucosal injection materials
        Gastrointestinal EndoscopyVol. 93Issue 3
        • Preview
          In 2020, we developed a next-generation submucosal injection material (NG-SIM) by devising a 2-solution-type SIM comprising 2.0% calcium chloride and 0.4% sodium alginate solutions.1 This NG-SIM achieved high performance and high flexibility. In 2019, shear-thinning hydrogel-based SIMs, which are easy to inject due to their low viscosity during injection and which form a highly viscous submucosal cushion after injection, were devised.2-4
        • Full-Text
        • PDF
      • The journey to develop the ideal submucosal injection solution for endoscopic submucosal dissection
        Gastrointestinal EndoscopyVol. 93Issue 2
        • Preview
          Endoscopic resection has been widely accepted as a minimally invasive treatment option for GI neoplasms without lymph node metastasis. Specifically, endoscopic submucosal dissection (ESD) allows for higher en bloc and R0 resection rates than does EMR. It provides long-term outcomes comparable with those of surgery while preserving organ function. However, ESD is technically challenging to perform, with longer procedure times and higher perforation rates than EMR. To avoid extraordinary struggle and intraoperative perforation during ESD, it is essential to have good visualization and access to the submucosal space.
        • Full-Text
        • PDF